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Re: ignatiusrielly35 post# 457538

Wednesday, 04/24/2024 4:47:27 PM

Wednesday, April 24, 2024 4:47:27 PM

Post# of 458325

former FDA experts have secretly left the company



At least one did, possibly two...there are so far done the chain the Chris will not PR their departure.

that we have noted experts who know how to handle regulatory processes.



Let's assume they are best in the world....They can not speed up the regulatory process...for sure they could improve the timeline for submission but it won't change the fact that it will still take months (many at that) to submit.

What is your best guess for submittal and approval (anywhere) assuming the secret top line data (for either PD, AD or RETT) is marginally good?


I say submittal in December 2024 and approval in September 2025...
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